The FOLL05 trial compared R-CVP with R-CHOP and R-FM regimens without rituximab maintenance in 504 patients enrolled at 58 sites from March 2006 to September 2010. A prior report at a median follow-up of 34 months showed an improved time to treatment failure at 3 years, the primary study endpoint, for R-CHOP and R-FM vs R-CVP, with R-CHOP exhibiting a better risk-benefit ratio with regard to toxicity than R-FM. The current post hoc analysis provides findings after a median follow-up of 84 months (range = 1–119 months).

Long-Term Outcomes

Among all patients, 8-year rates were 44% for treatment failure and 48% for progression-free survival. In an analysis adjusting for Follicular Lymphoma International Prognostic Index 2 scores, the hazard ratios for progression-free survival vs R-CVP were 0.73 for R-CHOP (P = .037) and 0.67 for R-FM (P = .009). Among all patients, 8-year overall survival was 83%, with no significant difference observed among the R-CVP (85%), R-CHOP (83%), and R-FM (79%) groups (P = .243).

The risk of death from lymphoma was comparable among study groups (P = .900). The risk of death from causes unrelated to lymphoma at 8 years was higher in the R-FM group vs the R-CVP group (11.2% vs 1.8%, P = .005), with no significant difference observed between R-CVP and R-CHOP (6.4%, P = .157). More patients in the R-CVP group required second-line therapy than did those in the R-CHOP and R-FM groups (55% vs 38% and 32%; P < .001).

The investigators concluded: “With an 83% 8-year [overall survival] rate, long-term follow-up of the FOLL05 trial confirms the favorable outcome of patients with advanced-stage [follicular lymphoma] treated with immunochemotherapy. The three study arms had similar [overall survival] but different activity and toxicity profiles. Patients initially treated with R-CVP had a higher risk of lymphoma progression compared with those receiving R-CHOP, as well as a higher risk of requiring additional therapy.”

The study was supported by grants from the Associazione Angela Serra per la Ricerca sul Cancro, Modena.